14 June 2018 Presentation: APIC Conference Coverage
Cori Ofstead, MSPH (President and CEO, Ofstead and Associates, St. Paul, MN) presented the findings of a prospective, multicenter study, which aimed to evaluate the effectiveness of reprocessing flexible bronchoscopes and endobronchial ultrasound (EBUS) bronchoscopes.
The study, funded by 3M Company and supported by Healthmark Industries, was recently published in an issue of CHEST Journal.1
The 2017 study was conducted in three large hospitals—including two transplant centers—on 24 clinically-used and two new bronchoscopes. The assessments included tests for residual contamination after cleaning and high-level disinfection (HLD) as well as visual inspections of the devices, observation of staff reprocessing activities, and the evaluation of storage cabinet cleanliness.
Bronchoscopes, a type of endoscope, are used for various diagnostic and therapeutic procedures including biopsy, removal of lung secretions, and resecting tumors or strictures.
Despite the number of illness and infection outbreaks linked to contaminated bronchoscopes,2 hospitals are not vigilant in their cleaning, disinfecting and storing procedures. Bronchoscopes should be reprocessed by following the product Instructions for Use (IFUs) and established hospital guidelines.
Minimum reprocessing guidelines:
- Bedside precleaning
- Leak testing
- Thorough cleaning and rinsing
- Verification of cleaning
- Sterilization or HLD
- Visual inspection before use
Debates on whether reusable bronchoscopes should undergo high-level disinfection (HLD) or sterilization are ongoing.3
Ofstead has conducted numerous studies on endoscopes for nearly 10 years. She recommends hospitals use sterilized or single-use scopes only. This study’s findings support her reasoning.
Reprocessing was not always sufficient.
This study found that all three sites were reprocessing bronchoscopes in GI endoscopy suites using automated endoscope reprocessors (AERs). All sites were using the same brand of AER with the same disinfectant. One site was observed performing most key steps well, but that site saw an increase in microbial cultures with growth after HLD.
Bronchoscopes at all sites had visible defects.
Each location was cited multiple times for dried fluid spots, scratches, residue in varying colors, fluid and debris. In a few instances, an unknown substance described as “sticky and oily” was present. It was found to be a silicone-based lubricant commonly used during bronchoscopy procedures.
The port on one scope contained visible black debris. Ports are known to be an area at high risk for contaminants.
Damaged bronchoscopes were in use at all sites.
Several visible irregularities were found inside the channels and ports. Scopes were squashed or dented. Fluid droplets were noted, and the inner lining of one channel was torn up, creating a loose, filamentous debris. Brown, rusty stains and white residue were found in more than one scope.
Storage conditions were insufficient to protect bronchoscopes.
Other than a somewhat high adenosine triphosphate (ATP; an indicator of cellular metabolism) level, one site kept their storage cabinet acceptably clean.
However, the remaining two sites had multiple breaches. These included an unplugged HEPA filter, disabled cabinet fans, and clutter and dust inside the cabinets.
High contamination levels were a problem at all three sites.
Testing revealed microbial cultures with growth at all sites following manual cleaning and HLD. When scopes were manually cleaned and then disinfected, the microbial growth at two sites reduced, but not to a satisfactory level.
At one site, the microbial growth increased from 20 percent to 50 percent post-HLD.
Overall, 58% of the bronchoscopes in the study revealed microbial growth after high-level disinfection.
Numerous species were identified post-manual cleaning and post-HLD including mold, E. coli/Shigella, and Sphingomonas phyllosphaerae. Hemoglobin was detected on one bronchoscope after manual cleaning.
Water quality was an issue at all sites.
AERs at all sites had visibly discolored water filters. Upon removal of the filters at one site, brown sludge and mold were observed. Waterborne pathogens were responsible for a contamination at another institution,1 which was likely linked to contaminated water filters.
1. Move toward the use of sterilized or single-use bronchoscopes.
2. Staff need to optimize system-wide policies.
In the meantime, when using sterile scopes is not possible, the staff needs to ensure that a quality assurance program is in place to reduce risk.
They can begin by addressing the issues contributing to risk:
- The co-mingling of GI endoscope and bronchoscopes
- The use of lubricants that cannot be removed
- Water quality issues in the reprocessing suite
- Inadequate bedside precleaning
- Delayed reprocessing
- Reprocessing protocol for evening and weekends
3. Stakeholders need to provide guidance and accountability for their staff.
Technicians should be properly trained and assessed using competency programs. Expert audits should be arranged to examine reprocessing and quality control practices.
Clearly, the results of this study indicate that quality control improvements are needed urgently at institutions that use reusable bronchoscopes.
Patients undergoing bronchoscopy are at a high risk for infection. Cleaned bronchoscopes are not free of potential pathogens that could prove catastrophic to critically-ill patients.
Ofstead stressed that, while anatomy exposed to bronchoscopes may not be sterile (i.e.: diseased lung tissues), bronchoscopes should be sterile with each use. Contamination of scopes accumulates over time, and as this study demonstrated, the necessary reprocessing steps are rarely completed in full.
1. CHEST Journal Article in Press https://journal.chestnet.org/article/S0012-3692(18)30802-X/pdf.
2. Ofstead CL. A multi-site study evaluating contamination and visual irregularities on flexible bronchoscopes. Oral presentation at Association for Professionals in Infection Control and Epidemiology; June 14, 2018; Minneapolis, MN.
3. Kovaleva J, Peters FT, van der Mei HC, et al., Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy. Clin Microbiol Reviews. 2013;26(2):231–254.